Digital Monitoring of Self-reported Symptoms by Patients Treated With Cabozantinib Plus Nivolumab for Advanced Clear-cell Renal Carcinoma (CANIQOL)

Centre Francois Baclesse

Status and phase: Enrolling; Phase 4

Conditions: Locally Advanced; Metastatic Renal Cell Carcinoma; Renal Cell Carcinoma (Kidney Cancer)

Treatments: Drug: cabozantinib and nivolumab

Study type: Interventional

Funder types: Other

Identifiers

NCT07028125

2024-518991-30-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

The aim of the study is to evaluate the impact of digital monitoring of self-reported symptoms (PROs) on the adjustment of treatment management in patients treated with cabozantinib plus nivolumab for advanced clear cell renal cell carcinoma (RCC) in real life during the first 3 months of combined treatment

Full description

Patients receive the combination of Cabozantinib and Nivolumab as indicated in the label.

During this combined treatment, the digital monitoring system is used to collect weekly data on treatment tolerance, based on patient reports.

Enrollment: 83 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient older than 18 years
• Diagnosis of advanced/metastatic Renal Cell Carcinoma (RCC) with a clear-cell component
• No prior systemic treatment for RCC
• Physician-initiated decision prior to study enrollment to treat with cabozantinib and nivolumab in combination, in first line for advanced/metastatic RCC, according to approved local labels
• Female subjects of childbearing potential must not be pregnant at screening and during treatment by Cabozantinib and Nivolumab. Effective methods of contraception must be used throughout the course of treatment and for at least 5 months after the end of treatment. Sexually active fertile subjects and their partners must agree to use medically accepted barrier methods of contraception (e.g., male or female condom) during the study and 5 months after the last dose of study treatment, even if oral contraceptives are also used.
• Subject affiliated to an appropriate social security system
• Patient has signed informed consents obtained before any trial related activities and according to local guidelines

Exclusion criteria

• Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol
• Current participation in another clinical study and/or in an investigational program with any intervention that could possibly interfere with the treatment and impact this study
• Patient with history of allergy or hypersensitivity to components of the study drugs
• Patient with contraindication to the study drugs
• Pregnant or lactating woman
• Patient unable to use digital tools
• Patient deprived of liberty or placed under the authority of a tutor
• Patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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83 participants in 1 patient group

Digital monitoring under Cabozantinib and nivolumab treatments

Experimental group

Description:

During this combined treatment, the digital monitoring system is used to collect weekly data on treatment tolerance by patient self-report. The digital telemonitoring platform is used to facilitate the monitoring of signs and symptoms of treatment-specific Adverse Events. The platform integrates an algorithm to define patient risk based on responses to data collected on platform. The self-reported information on the mobile digital device allows to "classify" patients ("correct", "compromised", "to be monitored", or "critical) and to create some alerts. Some actions may be undertaken depending on these alerts, with adjustments of the management of treatments

Treatment:

Drug: cabozantinib and nivolumab